Various ambulatory medical devices are known for treating and/or monitoring patients at a remote site away from the caregiver's or clinician's office. One example of an ambulatory medical device is a drug delivery device, such as a drug pump, for providing periodic or continuous drug delivery to the patient when the patient is away from the caregiver's office.
Certain drugs rarely achieve their maximum therapeutic action through conventional injection techniques. Many drugs reach their full potential only through precise delivery over an extended period of time. With controlled drug infusion through a drug pump, the drug can be given at a precise rate that will keep the drug concentration within the therapeutic margin and out of the toxic range. Ambulatory drug pumps can provide appropriate drug delivery to the patient at a controllable rate which does not require frequent medical attention and which allows the patient to leave the hospital or caregiver's office.
A failure to adequately monitor the drug pump and the patient's usage of the drug pump can reduce or eliminate any benefits the patient may have received from a proper drug delivery therapy. In some cases, the drug therapies can have serious health consequences to the patient if the drugs are not administered properly.
Several concerns arise when the patient utilizes the various ambulatory medical devices at remote sites. If the ambulatory medical device gathers data with respect to the device and/or the patient, the data needs to be easily accessible by the caregiver to permit the caregiver to monitor the device and the patient. Often, the patient may be of little or no assistance in accessing the data and communicating with the caregiver from the remote site. If the caregiver needs to physically handle the device to access the data, the device and caregiver must be brought to the same location.
Similar problems can also arise in that the medical devices may fail or be used improperly at the remote sites. If the device is not operating properly, the device may have to be brought to the caregiver, or the caregiver may have to visit the patient. If the caregiver attempts to trouble shoot from a remote site, the patient may be unable physically or mentally to sufficiently cooperate with the caregiver for the caregiver to trouble shoot from the remote site. Operating problems can arise at inconvenient times, such as at night or on weekends and holidays. The caregiver may also need to be able to easily periodically monitor the patient's usage of the medical device to observe patient compliance with prescribed treatments while the patient is at the remote site.
There may further arise a need for the caregiver to access the controller, such as the processor and the programs, which controls operation of the ambulatory medical devices. For example, in the case of drug delivery devices, some therapies change over time. The caregiver may need to access the operating program in order to change the operation of the drug delivery device. Further, some drug delivery devices, for example, may be used for very different applications, requiring different operating programs. These operating programs can be changed as the use of the drug delivery device changes. Resources may not be used efficiently if the caregiver and the device must be brought to the same location for the caregiver to access the processor and operating programs.
One specific situation often arises in the case of a drug pump where the caregiver needs to access the controller of the drug pump. The caregiver may visit the patient at the patient's home at some point after the drug therapy has begun using the drug pump. The caregiver may sample the patient's blood. The caregiver returns to the office and the blood sample is analyzed. The results of the blood analysis may indicate the patient is not receiving the proper drug therapy. This usually means the controller of the drug pump must be adjusted to give the proper therapy to the specific patient. To adjust the controller, the caregiver needs to be able access the controller.
Another problem facing caregivers in the area of ambulatory medical devices relates to the ease of remote communication with the devices, if such remote communication capability is provided. Remote communication with an ambulatory medical device using a personal computer or base station may be difficult for some caregivers, if the personal computer/base station operates differently than the medical device. The caregiver must then be knowledgeable both in operation of the medical device and in operation of the personal computer/base station. This concern also applies to local communication with the ambulatory medical device.
In the case of remote communication with a patient's medical device using a personal computer/base station, the caregiver also needs to remain near the personal computer/base station, or else transport the personal computer/base station with the caregiver, if the caregiver wishes to remain in communication with the patient's medical device.
It sometimes may become necessary to communicate with a personal computer or base station either locally or remotely in order to take advantage of the greater data handling or processing capability of the personal computer or base station, for example. The ability of the caregiver to communicate easily with the pump using a personal computer or base station may be important in those circumstances. In addition, the patient may be able to do very little to assist the caregiver in linking the remote medical device to the local personal computer/base station.
There is a need for systems and methods for communicating with ambulatory medical devices such as drug delivery devices, both locally and remotely, which addresses the above concerns and other concerns.